Feasibility study of a trial of arthroscopic surgery for hip impingement compared with non-operative care
| ISRCTN | ISRCTN09754699 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN09754699 |
| Protocol serial number | HTA 10/41/02 |
| Sponsor | University Hospitals Coventry & Warwickshire (UK) |
| Funder | Health Technology Assessment Programme |
- Submission date
- 20/02/2012
- Registration date
- 20/02/2012
- Last edited
- 16/09/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Damian Griffin
Scientific
Scientific
University of Warwick
Division of Health Sciences
Clinical Science Research Laboratories
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Feasibility study with a mulitcentre pilot randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | UK FASHIoN: Feasibility study of a trial of Arthroscopic Surgery for Hip Impingement compared with Non-operative care |
| Study acronym | UK FASHIoN |
| Study objectives | We plan to establish whether it is feasible to undertake an RCT of hip arthroscopy versus best conservative care for femoroacetabular impingement (FAI). More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/104102 Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0004/55408/PRO-10-41-02.pdf |
| Ethics approval(s) | NRES West Midlands, 15/02/2012, ref: 11/WM/0389 |
| Health condition(s) or problem(s) studied | Femoroacetabular impingement (FAI) |
| Intervention | Hip Arthroscopic Surgery - performed by an experienced trained surgeon. Non-operative care - this will comprise a package of best conservative care; treatment options, including interventions that target patients pain (anti-inflammatory medication, hip joint corticosteroid injection, postural adaptations, exercise, acupuncture, manual therapy techniques) and functional difficulties (lifestyle advice, gait modification, exercise and physical activity). The focus of this intervention will be an individualised, supervised and progressed exercise rehabilitation programme. Secondary sponsor: University of Warwick c/o Dr Peter Hedges (Director of Research Support Services) |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Non-Arthritic Hip Score (NAHS) |
| Key secondary outcome measure(s) |
1. IHOT-33 |
| Completion date | 01/09/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | All |
| Target sample size at registration | 60 |
| Key inclusion criteria | Current inclusion criteria as of 04/02/2013: 1. ≥ 16 years of age 2. They have symptoms of hip pain - they may also have symptoms of clicking, catching or giving way 3. They show radiographic evidence of pincer- or cam-type FAI on plain radiographs and cross-sectional imaging 4. The treating surgeon believes that they would benefit from arthroscopic FAI surgery 5. Able to give written informed consent 6. Able to participate fully in the interventions Previous inclusion criteria until 04/02/2013: 1. Aged 18-50 2. They have symptoms of hip pain - they may also have symptoms of clicking, catching or giving way 3. They show radiographic evidence of pincer- or cam-type FAI on plain radiographs and cross-sectional imaging 4. The treating surgeon believes that they would benefit from arthroscopic FAI surgery 5. Able to give written informed consent 6. Able to participate fully in the interventions |
| Key exclusion criteria | 1. They have previous significant hip pathology such as Perthes disease, slipped upper femoral epiphysis or avascular necrosis 2. They have had a previous hip injury such as acetabular fracture, hip dislocation or femoral neck fracture 3. They already have osteoarthritis, defined as Tonnis grade >150, or more than 2mm loss of superior joint space width on AP pelvic radiograph 4. There is evidence that the patient would be unable to participate fully in the interventions, adhere to trial procedures or to complete questionnaires, such as cognitive impairment or intravenous drug abuse |
| Date of first enrolment | 01/03/2012 |
| Date of final enrolment | 01/09/2013 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
University of Warwick
Coventry
CV2 2DX
United Kingdom
CV2 2DX
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2016 | Yes | No | |
| Results article | results | 01/10/2016 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
16/09/2016: Publication reference added.
05/05/2016: Publication reference added.
13/03/2012: study design updated from multi-centre single-blind randomised controlled trial to feasibility study with a mulitcentre pilot randomised controlled trial.
